Moderna Moves into Phase II Testing of COVID-19 Vaccine Candidate

Vaccine

Shares of Moderna jumped nearly 11% from the moment the bell rung this morning following its announcement that it received regulatory permission to begin a Phase II study of its mRNA vaccine candidate for COVID-19.

In a brief announcement this morning, Moderna said it expects to begin the mid-stage study soon with 600 patients and is finalizing protocols for a hoped-for Phase III study mRNA-1273, which is expected to begin in early summer of 2020.

Stéphane Bancel, Moderna’s chief executive officer, said the Phase II study is a crucial step in advancing the vaccine candidate as the company looks toward the goal of moving into Phase III. If all goes well, Bancel said the company is making plans to have a Biologics License Application for the vaccine up for approval in early 2021. Having a vaccine for COVID-19 available as quickly as possible is one step in helping society return to a greater sense of normalcy.

“We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” Bancel said in a statement.

The agreement with Lonza was struck only a few days ago to bolster the manufacture of the vaccine candidate that the world is hoping against hope will succeed in clinical trials. The two companies entered into a 10-year collaboration for large-scale manufacture of the company’s vaccine, mRNA-1273, as well as other potential Moderna products.

The Moderna vaccine candidate is an mRNA vaccine against SARS-CoV-2 that encodes for a prefusion stabilized form of the Spike (S) protein. As BioSpace has previously reported, the vaccine contains a section of messenger RNA that codes for a protein associated with COVID-19. When the vaccine is injected into a patient, the mRNA moves into the cells, where they then agitate the protein. The body’s immune system should then treat the protein like the virus and attack it, developing an immune response that it will then use if it comes into contact with the actual virus.

Moderna’s vaccine candidate is one of the more promising ones, according to Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Diseases, and the scientific face of the White House COVID-19 task force. In addition to the Moderna vaccine candidate, Fauci recently pointed to a candidate under development by researchers at Oxford University’s Jenner Institute. Fauci said that those two candidates are creating substantial immune responses in animal models and said the “promise is great.”

Development of Moderna’s vaccine candidate is being supported by a $483 million grant from the Biomedical Advanced Research and Development Authority (BARDA). The funds, awarded before the unexpected ouster of the agency’s director Rick Bright, are expected to accelerate the development of Moderna’s vaccine candidate.

There are more than 100 vaccine candidates in development, according to a recent report from the World Health Organization. Among those include a handful that have already entered clinical trials, including Moderna’s candidate. The most advanced in terms of clinical testing is CanSino’s Phase II trial assessing its Adenovirus Type 5 Vector, Ad5-nCoV.

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